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Daily Protein Intake Patterns on Energy Metabolism and the Motivation to Snack

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02795442
Recruitment Status : Recruiting
First Posted : June 10, 2016
Last Update Posted : March 6, 2020
Sponsor:
Information provided by (Responsible Party):
Shanon Casperson, USDA Grand Forks Human Nutrition Research Center

Brief Summary:
The purpose of this study is to determine if when one eats protein can change how the body uses food for energy. Researchers will also test if eating a high protein breakfast can change one's craving for snack foods.

Condition or disease Intervention/treatment Phase
Obesity Other: Even protein Other: Skewed protein Not Applicable

Detailed Description:
The purpose of this study is to determine if consuming 30 g of high-quality protein at each meal can increase fat utilization and shift between-meal snack choices. While the benefits of high-protein diets are well known, little is known about the optimal amount of protein that should be eaten at each meal. Most Americans eat little protein at breakfast and lunch and most of their protein at the evening meal. Current guidelines for protein are based on body weight; however, recent evidence indicates that absolute amounts of protein at each meal are needed to maintain metabolically active fat-free mass. This suggests that a more even protein consumption pattern across daily meals may positively influence energy metabolism. In addition, recent evidence indicates that protein may reduce activity in the food reward areas of the brain. This suggests that protein may influence between-meal snacking by decreasing the relative reinforcing value (RRV) of highly rewarding snack foods. The RRV of a food is an empirical measure of its motivating value and energy-dense foods are highly reinforcing, especially for obese individuals. This study will be the first to investigate the role of the daily distribution of protein intake on energy metabolism and modifying snacking behavior.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Daily Protein Intake Patterns on Energy Metabolism and the Motivation to Snack
Actual Study Start Date : June 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Even protein
Menu to provide 90 g of protein per day in an even distribution of 30 g at each meal.
Other: Even protein
5 day intake of even protein 3 day rotating menu.

Experimental: Skewed protein
Menu to provide 90 g of protein per day in a skewed distribution of 10 g at breakfast, 15 g at lunch and 65 g at dinner.
Other: Skewed protein
5 day intake of skewed protein 3 day rotating menu.




Primary Outcome Measures :
  1. Fat, carbohydrate, and protein utilization [ Time Frame: 4 hours after meal consumption ]
    The effect of consuming two patterns of daily protein intake on the use of fat, carbohydrate and protein for energy.

  2. Relative reinforcing value (RRV) of energy-dense snack foods [ Time Frame: 2 hours after breakfast consumption ]
    The effect of consuming a high-protein or a low-protein breakfast on the RRV of energy-dense snack foods to a healthy snack food alternative.


Secondary Outcome Measures :
  1. Peripheral neurotransmitter metabolites [ Time Frame: 2 hours ]
    The effect of consuming a high-protein or low-protein breakfast and an energy-dense snack food on dopamine and serotonin metabolite plasma concentrations.

  2. Psychoactive Effect Questionnaire [ Time Frame: 2 hours ]
    The effect of consuming a high-protein or low-protein breakfast and an energy-dense snack food on the number of positive responses on the Psychoactive Effects Questionnaire.

  3. Satiety visual analog scales [ Time Frame: 4 hours after meal consumption ]
    The effect of consuming two patterns of daily protein intake on subjective measures of satiety.



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI < 25 kg/m2
  • BMI ≥ 30 kg/m2 but < 34.5 kg/m2
  • able to understand and sign the informed consent
  • able to provide own transportation to the Center
  • free of any major illness/disease
  • usual protein intake within the acceptable macronutrient distribution range (10 to 30%)
  • constant habitual activity patterns within the last 3 months
  • females of childbearing age must be on birth control for a minimum of 3 months prior to study start and have regular menstrual cycles

Exclusion Criteria:

  • unable or unwilling to consume animal products
  • have had more than a 10% change in body weight within the past 2 months
  • are participating in a weight loss diet/exercise program
  • are consuming a specialized diet
  • currently or planning on becoming pregnant during the study timeline
  • lactating
  • have a metabolic illness/disease
  • have uncontrolled hypertension
  • have ever had cancer
  • have an infectious disease
  • suffer from alcohol or drug abuse
  • use tobacco and e-cigarette products on a regular basis
  • have the presence of acute illness
  • taking medications known to affect energy expenditure and appetite

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02795442


Contacts
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Contact: Shanon Casperson, PhD 701-795-8497 shanon.casperson@usda.gov

Locations
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United States, North Dakota
USDA Grand Forks Human Nutrition Research Center Recruiting
Grand Forks, North Dakota, United States, 58203
Contact: Angela J Scheett, MPH, RD    701-795-8386    angela.scheett@usda.gov   
Sponsors and Collaborators
USDA Grand Forks Human Nutrition Research Center
Investigators
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Principal Investigator: Shanon Casperson, PhD USDA Grand Forks Human Nutrition Research Center
Additional Information:
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Responsible Party: Shanon Casperson, Research Biologist, USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT02795442    
Other Study ID Numbers: GFHNRC500
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: March 6, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No